This Phase 2b/3, randomized, double-blind, placebo-controlled, 2-part study will evaluate the efficacy, safety and tolerability of different dose regimens of SPG601 in adult male participants with Fragile X syndrome.
Adult males aged 18 to 45 years, inclusive
Diagnosis of Fragile X as confirmed with genetic testing
Patient must have caregiver
Must be in good health with no significant medical history
Any physical or psychological condition that prohibits study completion
Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months.
Auditory or visual impairments that cannot be corrected
History of suicidal behavior or suicidal ideation